A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease

ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten.

Biological: ALV003

Placebo Comparator: Placebo

Excipients for ALV003 absent the experimental compounds

Biological: ALV003 placebo

Eligibility

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

History of biopsy-proven celiac disease

Adherence to a gluten-free diet

TG2 antibody negative

Signed informed consent

Exclusion Criteria:

Active dermatitis herpetiformis

History of IgE-mediated reactions to gluten

Use of specific medications 6 months prior to entry

History of alcohol abuse or illicit drug use

Current untreated or GI disease

Positive pregnancy test

Received any experimental drug within 14 days of randomization

Uncontrolled chronic disease or condition

Uncontrolled complications of celiac disease

Any medical condition which could adversely affect study participation

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255696